What is content uniformity in pharma?
Uniformity of Content is a pharmaceutical analysis parameter for the quality control of capsules or tablets. Multiple capsules or tablets are selected at random and a suitable analytical method is applied to assay the individual content of the active ingredient in each capsule or tablet.
How is content uniformity calculated?
The test for uniformity of content of single-dose preparations is based on the assay of the individual contents of active substance(s) of a number of single-dose units to determine whether the individual contents are within limits set with reference to the average content of the sample.
Why is content uniformity important?
Content uniformity is an important quality measure of the final solid dosage product, notes Ian Robertson, spectroscopy applications specialist at PerkinElmer. It ensures that a consistent dose of the API is maintained between batches so that the patient receives the correct dose.
What is AV value in content uniformity?
Criteria The requirements are met if the final acceptance value of the 30 dosage units is less than or equal to L1% and no individual content of the dosage unit is less than (1－ L2 × 0.01)M nor more than (1 ＋ L2 × 0.01)M in Calculation of Acceptance Value under Content Uniformity or under Mass Variation.
What is uniformity content test?
Content uniformity is one in a series of tests in a therapeutic product specification that assesses the quality of a batch. Testing for content uniformity helps ensure that the strength of a therapeutic product remains within specified acceptance limits.
What is the difference between assay and content uniformity?
The main difference between content uniformity and assay is that content uniformity is a test in which evaluation units are done individually whereas assay is a test in which multiple units are done simultaneously.
What information is found in USP 35?
It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.
When to use the content uniformity procedure?
The Content uniformity procedure may be used in all cases. The Weight variation procedure can be used where permitted as detailed in Table 1. The Weight variation procedure may be used for products for which it is permitted. 12. What is a simple way to express the acceptance criteria outlined in GC 905 in a product specification document?
What is the uniformity of dosage units General Chapter?
Added Content Uniformity procedure and criteria for semi solid dosage forms, and instructions to assay 10 units. The <905> Uniformity of Dosage Units General Chapter was incorporated into and became official with the Second Supplement to USP 34–NF 29.
How to test a multiple component tablet for uniformity?
1. We are testing a multiple component tablet for Uniformity of Dosage Units. One of the components meets the requirement for testing by the Weight variation procedure. If we test this one component and it passes the criteria in the chapter can we assume that the other components will pass too?
Why are pre metered dosage units removed from the USP?
As a result of harmonization, the separate procedures and criteria for transdermal systems, suppositories and inhalations in pre-metered dosage units were removed from the chapter. These dosage forms are now classified as Others and require the use of the Content uniformity procedure.
